Product Design Development Support
Decisions made in the early design phase are crucial as it will greatly impact on the future success of the medical device. Inzign’s dedicated team of engineers are always ready to guide customers along the design development phase. Inzign engineers aid customers in the development of prototypes and pilot assembly lines, as part of their approach to introduce the medical device to the market.
Inzign invested in a Objet 30 from Stratasys, a high precision 3D printer that prints rigid models for excellent detail visulization. Proven PolyJet 3D Printing is famous for smooth surfaces, fine precision and diverse material properties. It works a bit like inkjet document printing, but instead of jetting drops of ink onto paper, the print head jets microscopic layers of liquid photopolymer onto a build tray and instantly cures them with UV light. The fine layers build up to create a prototype or end-use part. Material available at Inzign are :
- Rigid opaque white (VeroWhitePlus)
- Rigid opaque black (VeroBlackPlus )
- Rigid opaque blue (VeroBlue)
- Rigid opaque gray (VeroGray)
- Polypropylene-like material (DurusWhite) for snap fit applications
Inzign’s manufacturing documents adhere to the FDA GMP guidelines for medical devices, which assists in the validation and verification of customer’s medical device production for FDA approval. Design Development phase focuses on having not only best medical device product design, but the most suitable manufacturing process that is repeatable, scalable and well-documented.
Streamlining, Standardizing, and Reducing the Number of Components
A major advantage to involving Inzign early on in the product design cycle is Inzign’s design for manufacturability assistance. Due to the years of experience in the manufacturing field, Inzign’s engineering and new product introduction team can identify possible design changes that do not affect the functionally of the device, while reducing tooling costs and making the manufacturing process more robust. Additional technologies such as over-molding and two shot can identify areas where two or more parts can be combined into a single component, streamlining the assembly process, all while maintaining the ability to easily scale up for larger production runs once the device reaches the marketplace.
Another area for potential cost reductions is the standardization of certain components. For example instead of having a left and right housing, create a single housing half that can function as both. Instead of molding a custom clip, use a standard one that is already on the market being produced by the millions and incorporate it into the device.
Inzign’s engineering team is here to help. With Inzign’s ability to quickly change over assembly lines and molding presses is due to the commitment to lean manufacturing, 5S, and operational excellence can scale as the customer’s needs grows and enter the marketplace.